Browse Drug Recalls

972 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 972 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 972 FDA drug recalls in TX.

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DateProductReasonClassFirm
Jul 9, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the pa... Class II CareFusion 213, LLC
Jul 1, 2026 Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg... Microbial Contamination of Sterile Products - out of specifications results were obtained for bac... Class I Victory Medical Center Pharmacy
Jun 24, 2026 Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, C... Failed Impurities/Degradation Specifications Class II QuVa Pharma, Inc.
Jun 11, 2026 Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Me... Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. Class II BioMed Laboratories, LLC.
Jun 11, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopr... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropy... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v is... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 10, 2026 Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, ... Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment in... Class II McKesson
May 28, 2026 BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility:... Class I CareFusion 213, LLC
May 28, 2026 BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-Sterility: Due to presence of Aspergillus penicillioides. Class I CareFusion 213, LLC
May 28, 2026 BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
May 28, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 21, 2026 Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in F... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research LLC
Apr 21, 2026 GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: ... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells phar... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg pe... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1... cGMP deviations. Class II Wells Pharma of Houston LLC
Jan 16, 2026 UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syrin... Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrect... Class I McKesson
Jan 6, 2026 AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each cGMP deviations. Class II Encon Safety Products Co
Dec 17, 2025 BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and I... Lack of Assurance of Sterlity Class II CareFusion 213, LLC
Dec 15, 2025 MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafi... Class I StuffbyNainax
Oct 29, 2025 POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly con... Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... Class I Otsuka ICU Medical LLC
Oct 29, 2025 POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly co... Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... Class I Otsuka ICU Medical LLC
Oct 27, 2025 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake... Lack of Assurance of Sterility: Potential for flexible container leaks. Class II Otsuka ICU Medical LLC
Oct 14, 2025 Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSE... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FO... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, ... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUB... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERIL... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERIL... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.